ZyCov-D (Coronavirus DNA Vaccine) / Zydus Lifesci - LARVOL DELTA

Development of novel genetic vaccine platforms: from the idea to GMP production. (ESGCT 2024) - "To address the urgent need to find solutions to the SARS-CoV-2 Pandemic, Takis has developed COVID-eVax, a vaccine approach based on genetic engineering and DNA electroporation as part of the X-eVax platform, previously developed...Recently, the first DNA vaccine against SARS-CoV-2 (ZyCov-D) has been registered in India for human use; moreover, DNA vaccines have been extensively tested in multiple clinical trials in the oncology field and are commonly used in veterinary medicine...This novel form of nucleic-acid vaccine has already proven to be efficacious in preventing SARS-CoV-2 infection in feline and ferret animal model. In this presentation, opportunities and challenges of DNA-based vaccines and Takis biotech experience will be discussed."

Infectious Disease • Respiratory Diseases

An Outline of the Immunogenic Potential of Progressing SARSCoV- 2 Vaccine Technologies among Children and Adolescents. (PubMed, Recent Pat Biotechnol) - "Currently, the WHO is analyzing emerging evidence to issue an emergency use list of vaccines for vaccinating children and adolescents."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Lipid nanoparticle-encapsulated DNA vaccine robustly induce superior immune responses to the mRNA vaccine in Syrian hamsters. (PubMed, Mol Ther Methods Clin Dev) - "To date, only one DNA vaccine (ZyCoV-D) has been authorized for emergency use in India...Here, we report that plasmid encoding a trimeric spike protein with LNP delivery (pTS/LNP), similar to those in Moderna's COVID-19 vaccine, induced more effective humoral responses than naked pTS or pTS delivered via electroporation...Importantly, pTS/LNP immunization exhibits enhanced cross-neutralizing activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and protects hamsters from the challenge of SARS-CoV-2 (Wuhan strain and the Omicron BA.1 variant). This study indicates that pDNA/LNPs as a promising platform could be a next-generation vaccine technology."

Journal • Lipid Nanoparticle • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

DNA Vaccines: Their Formulations, Engineering and Delivery. (PubMed, Vaccines (Basel)) - "Along with the successful COVID mRNA vaccines, the first DNA vaccine for human use, the Indian ZyCovD vaccine against SARS-CoV-2, was approved in 2021...We then cover some of the emerging science in the field of DNA vaccines, notably efforts to optimize delivery systems, better engineer delivery apparatuses, identify optimal delivery sites, personalize cancer immunotherapy through DNA vaccination, enhance adjuvant science through gene adjuvants, enhance off-target and heritable immunity through epigenetic modification, and predict epitopes with bioinformatic approaches. We also discuss the major limitations of DNA vaccines and we aim to address many theoretical concerns."

Journal • Review • Gene Therapies • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Immune responses, therapeutic anti-tumor effects, and tolerability upon therapeutic HPV16/18 E6/E7 DNA vaccination via needle-free biojector. (PubMed, mBio) - P2 | "For example, vaccination of patients with the ZyCoV-D DNA vaccine using the Tropis device is effective against COVID19, well tolerated, and licensed. Here we show that split-dose, multi-site administration and intradermal delivery via the Tropis biojector increase the delivery of pBI-11 DNA vaccine, enhance HPV antigen-specific CD8+ T-cell responses, and improve anti-tumor therapeutic effects, suggesting its translational potential to treat HPV16/18 infection and disease."

Journal • Cervical Cancer • Head and Neck Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Solid Tumor • CD8

Nucleic acid-based vaccine platforms against the coronavirus disease 19 (COVID-19). (PubMed, Arch Microbiol) - "Several DNA-based (ZyCoV-D, INO-4800, AG0302-COVID19, and GX-19N) and mRNA-based (BNT162b2, mRNA-1273, and ARCoV) approved vaccine platforms have been utilized for the COVID-19 prevention. Intracellular delivery of nucleic acid-based vaccines and their adverse events needs further research. Considering re-emergence of the COVID-19 variants of concern, vaccine reassessment and the development of polyvalent vaccines, or pan-coronavirus strategies, is essential for effective infection prevention."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Needle-free injection system delivery of ZyCoV-D DNA vaccine demonstrated improved immunogenicity and protective efficacy in Rhesus macaques against SARS-CoV-2. (PubMed, J Med Virol) - "Besides this, it also induced increased lymphocyte proliferation and cytokine response. The minimal viral load post-SARS-CoV-2 challenge and significant immune response in the immunized animals demonstrated efficiency of NFIS in delivering 2mg ZyCOV-D vaccine candidate."

Journal • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

China just approved the world's first inhaled Covid-19 vaccine mist (Interesting Engineering) - "'Once [Omicron] gets in through our nasal mucosa, or our oral mucosa, upper airway. That's game over [for] infection,' ...Eric Topol said recently in a podcast with U.S. President Joe Biden's former COVID-19 Response Coordinator...'The best way...to induce the mucosal immunity right at the upper airway is with either nasal or oral vaccines.'"

Media quote • Novel Coronavirus Disease

"Vaccinate every child against COVID-19": A scientific or socioeconomic need? (PubMed, J Family Med Prim Care) - "Out of 299 vaccine candidates, 28 are available to the general population in less than 1 year.[2] For children, WHO permitted vaccine Pfizer/BioNTech, Sinovac, and Sinopharm, Drug Controller General of India's approved ZyCov-D and Covaxin, and the Cuban government approved Soberna 2, and Soberna plus are available.[3] Italy, Germany, France, Norway, Switzerland, Israel, Dubai, Japan, Canada, and the US have already started vaccinating their children. Vaccinating children is not easy as it has taken nearly 1 year to vaccinate half of the adult Indian population. In these circumstances, rather than "vaccine for all," "vaccine for (chronically) ill" is the only feasible solution for children."

Journal • Review • Infectious Disease • Novel Coronavirus Disease

Immunologic response, Efficacy, and Safety of Vaccines against COVID-19 Infection in Healthy and immunosuppressed Children and Adolescents Aged 2 - 21 years old: A Systematic Review and Meta-analysis. (PubMed, J Clin Virol) - "Data were collected about multiple vaccines including BNT162b2 (Pfizer), mRNA-1273 (Moderna), JNJ-78436735 (Johnson and Johnson), CoronaVac (Sinovac), BBIBP-CorV (Sinopharm), adenovirus type-5-vectored vaccine, ZyCov-D, and BBV152 (COVAXIN)...Also, according to the meta-analysis, the efficacy and immune response of vaccines after the first and second doses were 91% and 92%, respectively. Meanwhile, overall immune response for all vaccines was 95% and 91% for Pfizer vaccine."

Journal • Retrospective data • Review • Cardiovascular • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease

PharmaJet (BIO 2022) - "Our NFIS addresses vaccine hesitancy with a preferred patient and caregiver experience, and we have established a proven path to commercialization, most recently as the exclusive delivery technology for ZyCov-D, the world’s first, commercialized-for-human-use, plasmid DNA vaccine...Our hand-held needle-free medical devices are also safe, fast, and easy-to-use and address common injection concerns such as needle-stick injuries, needle reuse and needle-phobia. With registrations in over 25 countries, PharmaJet is prepared to contribute to equitable vaccine access."

Vaccine For Kids: When cases increase in schools, three vaccines have come for children, Covaxin, ZyCovD and Corbevax approved - "On Tuesday, Professor Peter Hotez...said that there is a stock of 150 million doses available."

Media quote • Novel Coronavirus Disease

"Health Bulletin 27/April/2022 @GSK,@BharatBiotech,@NMC_IND,@ZydusUniverse #GSK #COPD #Inhaler-TripleTherapy #TrelegyEllipta #Covid #NMC #MBBSAdmission #Covaxin #Corbevax #ZycovD #MedicalColleges https://t.co/KPOTRv0LRn" (@medicaldialogs)

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

"Zycov-D is also thermostable...though not this much" (@dr_puneet)

Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India. (PubMed, Lancet) - "In this interim analysis, ZyCoV-D vaccine was found to be efficacious, safe, and immunogenic in a phase 3 trial."

Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"مجهزين لنا شي ؟ 😏 @illumina @WHO @DARPA @WellcomeLeap @CEPIvaccines #PharmaJet #DIOSynVax #ZyCov_D #Disease_X #Lassa" (@Janus33G)

Clinical

"India's first needle free covid vaccine Zycov-D launched In Patna.(Bihar)" (@raginisahu2007)

Clinical • Novel Coronavirus Disease

"Children's vaccines #ZyCov-D will be first introduced in 7 states Bihar, Jharkhand, Maharashtra, Punjab, Tamil Nadu, Uttar Pradesh & West Bengal National training for ZyCoV-D Completed ✅ Huge positive for CADILA Kids population 30% of total population of India 🇮🇳" (@hiddengems777)

Clinical

Covid-19 vaccines and variants of concern: A review. (PubMed, Rev Med Virol) - "All nine had an efficacy over 50% against symptomatic Covid-19 disease: NVX-CoV2373 (∼96%), BNT162b2 (∼95%), mRNA-1273 (∼94%), Sputnik V (∼92%), AZD1222 (∼81%), BBIBP-CorV (∼79%), Covaxin (∼78%), Ad26.CoV.S (∼66%) and CoronaVac (∼51%)...Promising Covid-19 vaccines such as WIBP-CorV, AD5-nCOV, ZyCoV-D, CVnCoV, EpiVacCorona and ZF2001 have advanced to clinical studies. This review describes the most relevant mutations in the SARS-CoV-2 spike protein, discusses VE against VOCs, presents rare adverse events after Covid-19 vaccination and introduces some promising Covid-19 vaccine candidates."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

[VIRTUAL] ZyCoV-D COVID-19 DNA Vaccine (VACCINES SUMMIT 2021) - No abstract available

Infectious Disease • Novel Coronavirus Disease

Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India. (PubMed, EClinicalMedicine) - "ZyCoV-D vaccine is found to be safe, well-tolerated and immunogenic in the Phase 1 trial. Our findings suggest that the DNA vaccine warrants further investigation."

Clinical • Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Immunogenic potential of DNA vaccine candidate, ZyCoV-D against SARS-CoV-2 in animal models. (PubMed, Vaccine) - "Based on the animal studies proof-of-concept has been established and preclinical toxicology (PCT) studies were conducted in rat and rabbit model. Preliminary animal study demonstrates that the candidate DNA vaccine induces antibody response including neutralizing antibodies against SARS-CoV-2 and also elicited Th-1 response as evidenced by elevated IFN-γ levels."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG

"1. @sputnikvaccine 2. @JNJNews/@biological_e 3. @SerumInstIndia/@Novavax Covovax 4. @ZydusUniverse ZyCov-D 5. @BharatBiotech BBV154" (@DKMCooper)

Zydus gets nod for to begin phase 3 trials of its Covid-19 vaccine in India (Livemint) - "Drug firm Zydus Cadila on Friday announced that it has received approvals to start Phase III clinical trials of its Covid-19 vaccine candidate ZyCoV-D in India. 'The trials for the vaccine are underway and will be tested across 60 locations in 30,000 healthy adult volunteers in India,'..."

New P3 trial • Infectious Disease • Novel Coronavirus Disease

Zydus Cadila seeks govt nod to start Phase-III clinical trials of COVID-19 vaccine (The Economic Times) - P2, N=1,000; "...the company is seeking regulatory approval to commence Phase-III trials....'The company is now planning to initiate Phase III clinical trials in around 30,000 volunteers upon receiving necessary approvals,'...The Phase-II study of the vaccine, ZyCoV-D, had been conducted in over 1,000 healthy adult volunteers...The vaccine was found to be safe and immunogenic, he added. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to the Central Drugs Standard Control Organisation (CDSCO) regularly..."

New P3 trial • P2 data • Infectious Disease • Novel Coronavirus Disease